- Intertek (Boxborough, MA)
- Project Engineer - Medical Device Testing, Boxborough, MA Intertek is a Nationally Recognized Testing Lab (NRTL) and leading provider of quality and ... quality, safety, and sustainability to life. What are we looking for? The Project Engineer is responsible for independently performing testing and evaluation on… more
- Takeda Pharmaceuticals (Lexington, MA)
- …support lifecycle management of commercial combination product. The Staff Device Engineer has extensive experience in medical devices for drug delivery ... of my knowledge. **Job Description** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for...with medical device and combination device regulations. + Lead project execution activities… more
- Capgemini (Burlington, MA)
- …_ERD PPL US_ **Title:** _Senior Embedded Software Engineer - Test Lead (Embedded Medical Device )_ **Location:** _MA-Burlington_ **Requisition ID:** _079670_ ... **About the job you're considering** Test Lead (Embedded Medical Device ) Test Lead to drive...requirements, use cases, and system specifications to fully understand project details and align test coverage with product expectations.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …well as external vendors, consultants, testing partners and service providers; create medical device and laboratory documentation such as SOPs; manage projects ... the following job opportunity: **JOB LOCATION:** Lexington, MA **POSITION** : Staff Engineer , Device Testing **POSITION DESCRIPTION** : Takeda Development Center… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... **Position Overview** The LEAD PROJECT TEAM SUPPORT ENGINEER -MI provides remote...manages. + Maintains an expert working knowledge of current medical imaging products and related technologies. + May be… more
- Fujifilm (Boston, MA)
- …of Synapse product implementation, fromsolution validation phases through product go-live. The Project Engineer (PE) must have wellrounded knowledge in all areas ... + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Medtronic (Boston, MA)
- …degree with 2+ years of engineering experience **Nice to Have:** * 5-7 years of medical device engineering experience * Experience with a large company with a ... Medical product development experience including hands-on experience with medical /surgical devices/instruments; familiarity with medical device … more
- Olympus Corporation of the Americas (Westborough, MA)
- …product security, cybersecurity, and equipment development oversight. Extensive knowledge of medical device design control requirements, system design and ... project and engineering leadership in all phases of device development, as well as ensure compliance to applicable...for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their… more
- Amgen (Cambridge, MA)
- …experience with 5+ years of experience in operations/manufacturing environment. + Medical device industry experience and regulated work environment experience. ... the lives of patients while transforming your career. Senior Engineer **What you will do** Let's do this. Let's...Regulation - 21CFR820, Risk Management - ISO 14971, EU Medical Device requirements - Council Directive 93/42/EEC.… more
- Amgen (Cambridge, MA)
- …of progressive experience as an engineer or scientist in relevant fields ( medical device development, manufacturing, etc.) + Proven track record of executing ... various global manufacturing sites. This role requires a deep understanding of medical device design, manufacturing processes, and regulatory requirements. Key… more
- BJs Wholesale Club (Marlborough, MA)
- …Leave, Jury Duty * Benefit plans for your changing needs* o Three medical plans**, Health Savings Account (HSA), two dental plans, vision plan, flexible spending ... least 18 years old) *eligibility requirements vary by position ** medical plans vary by location Job Summary: We are...Job Summary: We are looking for a Senior Mobility Engineer to join our team. This person will serve… more
- Amgen (Cambridge, MA)
- …automate model creation and post/processing. + Experience with combination products and device regulatory requirements, medical device development and design ... Join us and transform the lives of patients while transforming your career. Senior Engineer - Modelling and Simulation **What you will do** Let's do this. Let's… more
- Fresenius Medical Center (Waltham, MA)
- …a CAPA through the Quality System. + Knowledge and experience in CAPA and medical device product documentation procedures with proven ability or project ... **PURPOSE AND SCOPE:** The Senior Engineer , CAPA is responsible for coaching CAPA Engineers...will act as CAPA lead to CAPA Owner/Team providing project direction throughout CAPA stages. Performs Quality Approver functions… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …devices. + Knowledge and experience developing products under FDA and European Community medical device regulations and standards. + Excellent verbal and written ... devices. + 7+ years' experience as a systems engineer , leading the architectural design and systems engineering of...and systems engineering of complex, real time embedded system medical devices. + Project management experience and… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... **Position Overview** An Imaging Service Engineer II is responsible for performing scheduled and...of this job: This position typically works in usual medical , clinical working environments, including sites under construction. **The… more
- Integra LifeSciences (Boston, MA)
- …related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years of ... and set new standards of care. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is...testing activities. The role works closely with Product Development, Project Management, Regulatory, Marketing and Medical Affairs.… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Curtiss-Wright Corporation (Tewksbury, MA)
- Embedded Software Development Engineer , Senior - Onsite Ashburn, VA or Massachusetts We are looking for creative software developers who have a passion to invent, ... job will be to create or modify Board Support Packages (BSPs), device drivers, power-on firmware (BIOS/U-Boot), built-in test and design verification test software… more
- RTX Corporation (Marlborough, MA)
- …end users to protect people and property. As a **Senior** **Hardware Systems Engineer ** you will join our Hardware and Infrastructure Engineering Team as part of ... support to existing fielded systems. We are seeking an electrical/systems engineer with experience in electronic design, comfortable working with commercial… more
- Integra LifeSciences (Boston, MA)
- …related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years ... and communicating testing activities. The role works with Product Development, Project Management, Regulatory, Marketing and Medical Affairs. **ESSENTIAL DUTIES… more